Drug Information>Study Interpretation Practice Test

In a 24-week, multicenter, double-blind, randomized, placebo-controlled trial, 640 adults with type 2 diabetes inadequately controlled on metformin (baseline A1c 8.3%) were assigned to Drug X 10 mg once daily or placebo. The primary endpoint was change in A1c at week 24. Drug X produced a greater mean A1c reduction than placebo (−0.9% vs −0.3%); the between-group difference was −0.6% (95% CI −0.8 to −0.4; p<0.001). Secondary outcomes included weight change (−2.1 kg vs −0.3 kg) and rates of hypoglycemia (similar between groups). Nausea occurred more frequently with Drug X (18% vs 6%), leading to discontinuation in 3% vs 1%. Serious adverse events were comparable. The study was not powered for cardiovascular outcomes or durability beyond 24 weeks.

Background: This multicenter, double-blind, randomized, placebo-controlled trial evaluated the effect of amlodipine 5-10 mg daily versus placebo on clinic systolic blood pressure (SBP) over 12 weeks in adults with untreated stage 1-2 hypertension. Primary endpoint: change in mean seated SBP from baseline to week 12. Secondary endpoints: diastolic BP and adverse events. A total of 480 patients were randomized (mean age 54 years; baseline SBP 153 mmHg). At week 12, amlodipine reduced SBP by 18.6 mmHg versus 10.1 mmHg with placebo, yielding a between-group difference of 8.5 mmHg (95% CI 6.7 to 10.3; p<0.001). Diastolic BP decreased similarly (difference 5.2 mmHg; p<0.001). Rates of peripheral edema and dizziness were comparable; no serious drug-related events occurred.